1. Field of the Invention
The present invention is directed to dried blood spots, and in particular, to systems and methods of obtaining and sampling dried blood spots for the analysis thereof.
2. Description of Related Art
In 1963 Guthrie developed a method for collecting blood samples on absorbent filtration media. The blood samples were dried and transported to the laboratory for analysis. Today, dried blood spots (DBS) are used for mandatory newborn screening programs in the U.S. and in many other nations worldwide. DBS methods have also become common in other medical and forensic applications.
With the advancement of analyte detection methods, primarily liquid chromatography combined with mass spectroscopy (LC-MS or LC-MS/MS), interest has been expanded for the use of DBS for preclinical and clinical applications in lieu of plasma. The small blood volumes required, and the lower transportation and storage costs, are the driving factors. For preclinical applications, there is a significant reduction in the number of animals that are sacrificed, contributing to the ethics of DBS. Dried blood spots are also stable for an extended period of time, often measured in years if the DBS is kept dry. This eliminates the cold storage and shipping requirement needs of plasma, which will drastically reduce costs.
A change from plasma to DBS creates many new challenges to meet the requirements of public health. For the last two years, extensive method development for DBS has occurred in the Bioanalytical market to meet the requirements that are being defined by the U.S. Food and Drug Administration (hereinafter “FDA”) for meeting public health safety standards. The FDA, as the guardian of public health, will accept DBS studies only after they have met or exceeded predefined health standards that have been established for plasma. The present invention addresses such needs.